E. Alvarez et al., THE LONG-TERM SAFETY OF ALPROSTADIL (PROSTAGLANDIN-E-1) IN PATIENTS WITH ERECTILE DYSFUNCTION, British Journal of Urology, 82(4), 1998, pp. 538-543
Objective To evaluate the long-term safety and efficacy of intracavern
osal alprostadil (prostaglandin E-1, PGE(1)) in patients with erectile
dysfunction [ED) and assess the feasibility of self-injection treatme
nt, Patients and methods The study included 848 men (aged 18-75 years)
with ED of greater than or equal to 4 months' duration. The initial h
ome-use dose of alprostadil, defined as a dose producing an erection s
atisfactory for intercourse and lasting for greater than or equal to 2
0 min, was determined for each patient in the investigator's clinic an
d in the patient's home. This dose-finding phase was followed by a 6-m
onth, self-injection, home-maintenance phase. The efficacy and adverse
effects were documented. Results An initial home-use dose was determi
ned for 93% of the patients and in most (86%) it was less than or equa
l to 20 mu g. During the 6-month study period, 88% of injections asses
sed by the patients resulted in satisfactory sexual activity (intercou
rse or masturbation) and 90% of injections assessed, by partners resul
ted in satisfactory intercourse. Penile pain occurred in 44% of patien
ts, but this incidence decreased with time. In 52% of patients with pa
in it was mild and only 3% of patients discontinued the study because
of pain. Prolonged erection and priapism occurred in 8% and 0.9% of pa
tients, respectively, Penile fibrosis occurred in 4% of patients. Drug
-related systemic medical events occurred in 5%, of patients and none
of these were serious. Haemodynamic events occurred in <I% of patients
and were not considered to be clinically relevant. Conclusion Intraca
vernosal alprostadil is an effective and safe therapy for EU, provided
that the individual dose is established by titration, patients are tr
ained in the self-injection technique and supervised periodically.